MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MAPLE GROVE QUANTUM¿ MAVERICK¿; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

Model Number H7493808012270

Device Problems Break (1069); Device Damaged Prior to Use (2284)

Patient Problem No Patient Involvement (2645)

Event Date 03/15/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that shaft break occurred.During unpacking of a 2.75mm x 12mm quantum¿ maverick¿ balloon catheter, it was noted that the device delivery shaft was fractured.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was stable.

Manufacturer Narrative

Device evaluated by mfr., eval summary attached, method codes, result codes, conclusion codes updated.Device evaluated by mfr.: returned product consisted of a quantum maverick balloon catheter.The balloon, tip, hypotube and shaft were examined.The hypotube shaft was completely separated 92cm from the hub.The fracture faces were oval as if kinked prior to separation.There were numerous hypotube kinks.The investigation conclusion is handling damage as the complaint was caused by handling of the device or portion of the device without direct patient contact.(b)(4).

Event Description

It was reported that shaft break occurred.During unpacking of a 2.75mm x 12mm quantum¿ maverick¿ balloon catheter, it was noted that the device delivery shaft was fractured.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was stable.

• Brand Name: QUANTUM¿ MAVERICK¿
• Type of Device: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC - MAPLE GROVE; one scimed place; maple grove MN 55311
• MDR Report Key: 7453793
• MDR Text Key: 106269973
• Report Number: 2134265-2018-03341
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08714729392668
• UDI-Public: 08714729392668
• Combination Product (y/n): N
• PMA/PMN Number: P860019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 03/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/21/2020
• Device Model Number: H7493808012270
• Device Catalogue Number: 38080-1227
• Device Lot Number: 21286087
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2018
• Initial Date Manufacturer Received: 03/29/2018
• Initial Date FDA Received: 04/24/2018
• Supplement Dates Manufacturer Received: 05/02/2018
• Supplement Dates FDA Received: 05/29/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1